Glaucoma, SuspectDPSSPNCT03978546
Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)
A study testing Humphrey Visual Field Test, Optical Coherence Tomography (OCT) Scan and Smart Perimetry - Henson 9000 in people with Glaucoma, Suspect and Glaucoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Suspect, Glaucoma
- What is being tested?
- Humphrey Visual Field Test, Optical Coherence Tomography (OCT) Scan and Smart Perimetry - Henson 9000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reliable SAP visual field results (fixation loss < 33%, false positive < 15% and false negative < 20%).
- Visual acuity better or equal to 0.20 logMAR.
- Spherical refractive error within -6.00 to +6.00D and cylindrical error <2.00D
- No ocular co-morbidity likely to affect the visual field or OCT results.
- Age: 40-80 yrs
- Additional inclusion criteria for glaucomatous group:
Show all 11Show fewer
- Optic disc showing glaucomatous changes.
- SAP MD not worse than -6dB
- Additional inclusion criteria non-glaucoma group:
- Normal SAP visual field data (MD, PSD, GHT within normal range)
- No evidence of glaucoma or other Ocular co-morbidity in the eye suitable for the study.
Who cannot join
- Anomalous discs, Tilted discs, myopic discs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).
Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients.
Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP 24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. The sensitivity and specificity of the SAP and SSP tests will be established along with test duration. The size and location of defects established with both the SAP and SSP strategies will also be compared.
- Conditions
- Glaucoma, Suspect, Glaucoma
- Being tested
- Humphrey Visual Field Test, Optical Coherence Tomography (OCT) Scan, Smart Perimetry - Henson 9000
- Keywords
- glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humphrey Visual Field TestDiagnostic test
SITA Standard and 24-2 and 10-2 visual field tests
Optical Coherence Tomography (OCT) ScanDiagnostic test
Circle and Wide Angle Scans
Smart Perimetry - Henson 9000Diagnostic test
24+10-2 Smart Supra test
| Study group | Role | What they receive |
|---|---|---|
| Non-Glaucoma Patient Arm | Experimental | All participants will complete the same assessments Receives: Diagnostic Test: Humphrey Visual Field Test; Diagnostic Test: Optical Coherence Tomography (OCT) Scan; Diagnostic Test: Smart Perimetry - Henson 9000 |
| Glaucoma Patient Arm | Experimental | All participants will complete the same assessments Receives: Diagnostic Test: Humphrey Visual Field Test; Diagnostic Test: Optical Coherence Tomography (OCT) Scan; Diagnostic Test: Smart Perimetry - Henson 9000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of smart supra perimetry
Area under the curve for Smart Suprathrold Perimetry using probability thresholds to differentiate early glaucoma from non-glaucomatous visual fields.
Measured: 12 months
Secondary outcomes (2)
Diagnostic performance of Optical Coherent Tomography
Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.
Measured: 12 months
Diagnostic performance of Standard Automated perimetry
Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start11 Jun 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, SuspectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- All participants will have the same examinations but in a randomised order, these examinations are: Humphrey Visual Fields Test (10-2 and 24-2, SITA Standard), OCT Scan (Cube scan, Wide angle and macula scan) and Smart Perimetry - Henson 9000.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester, Columbia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978546
- Sponsor's protocol ID
- 250459
- Acronym
- DPSSP
- Status last verified
- Aug 2022
- First submitted
- 16 May 2019
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sukumar S, Harper RA, Tsamis E, Hood D, Henson DB. Diagnostic Accuracy of Smart Supra Perimetry in Comparison With Standard Automated Perimetry in the Detection of Early Glaucoma. J Glaucoma. 2025 Sep 1;34(9):710-718. doi: 10.1097/IJG.0000000000002596. Epub 2025 May 14.
PubMed 40366217
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).
- ClinicalTrials.gov ID
- NCT03978546
- Acronym / sponsor ID
- DPSSP / 250459
- Conditions
- Glaucoma, Suspect, Glaucoma
- Keywords
- glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester, Columbia University
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients.
Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP 24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. The sensitivity and specificity of the SAP and SSP tests will be established along with test duration. The size and location of defects established with both the SAP and SSP strategies will also be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will have the same examinations but in a randomised order, these examinations are: Humphrey Visual Fields Test (10-2 and 24-2, SITA Standard), OCT Scan (Cube scan, Wide angle and macula scan) and Smart Perimetry - Henson 9000.
| Arm | Type | Receives |
|---|---|---|
| Non-Glaucoma Patient Arm | Experimental | Diagnostic Test: Humphrey Visual Field Test, Diagnostic Test: Optical Coherence Tomography (OCT) Scan, Diagnostic Test: Smart Perimetry - Henson 9000All participants will complete the same assessments |
| Glaucoma Patient Arm | Experimental | Diagnostic Test: Humphrey Visual Field Test, Diagnostic Test: Optical Coherence Tomography (OCT) Scan, Diagnostic Test: Smart Perimetry - Henson 9000All participants will complete the same assessments |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Reliable SAP visual field results (fixation loss < 33%, false positive < 15% and false negative < 20%).
- Visual acuity better or equal to 0.20 logMAR.
- Spherical refractive error within -6.00 to +6.00D and cylindrical error <2.00D
- No ocular co-morbidity likely to affect the visual field or OCT results.
- Age: 40-80 yrs
Key exclusion criteria (1 listed)
- Anomalous discs, Tilted discs, myopic discs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humphrey Visual Field TestSITA Standard and 24-2 and 10-2 visual field tests | Diagnostic test | Glaucoma Patient Arm, Non-Glaucoma Patient Arm |
| Optical Coherence Tomography (OCT) ScanCircle and Wide Angle Scans | Diagnostic test | Glaucoma Patient Arm, Non-Glaucoma Patient Arm |
| Smart Perimetry - Henson 900024+10-2 Smart Supra test | Diagnostic test | Glaucoma Patient Arm, Non-Glaucoma Patient Arm |
Primary outcome
Diagnostic performance of smart supra perimetry
Time frame: 12 months
Area under the curve for Smart Suprathrold Perimetry using probability thresholds to differentiate early glaucoma from non-glaucomatous visual fields.
2 secondary outcomes
Diagnostic performance of Optical Coherent Tomography
Time frame: 12 months
Diagnostic performance of Standard Automated perimetry
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 40366217Sukumar S, Harper RA, Tsamis E, Hood D, Henson DB. Diagnostic Accuracy of Smart Supra Perimetry in Comparison With Standard Automated Perimetry in the Detection of Early Glaucoma. J Glaucoma. 2025 Sep 1;34(9):710-718. doi: 10.1097/IJG.0000000000002596. Epub 2025 May 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humphrey Visual Field Test, Optical Coherence Tomography (OCT) Scan and Smart Perimetry - Henson 9000 in people with Glaucoma, Suspect and Glaucoma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of smart supra perimetry (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.